Knee Replacement Clinical Trials

Clinical trials related to Knee Replacement Procedure

Comparing High Intensity Stretch Device Combined With Physical Therapy Versus Physical Therapy Alone to Prevent Motion-Restoring Surgery Following Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn whether adding a stretching device to standard physical therapy can help people regain knee bending after total knee replacement surgery. Some people have difficulty bending their knee during recovery. When this happens, doctors may recommend another procedure called motion-restoring surgery to improve knee movement. This study aims to answer two main questions. First, does adding a hydraulic high-intensity stretching device to physical therapy help people regain knee bending after surgery? Second, does using the device affect recovery, daily activities, or the chance of needing another procedure? Researchers will compare two treatment approaches. One group will receive standard physical therapy alone. The other group will receive standard physical therapy and will also use a hydraulic high-intensity stretching device called the Ermi Knee Flexionater at home. Participants who receive the device will use it at home each day in addition to attending their physical therapy sessions. Researchers will measure how well participants can bend their knee and will ask questions about pain, daily function, and activity level. Participants will also complete simple walking and mobility tests. Study visits will occur about four weeks after surgery when participants enroll, and again at about eight weeks, twelve weeks, six months, one year, and two years after surgery. Researchers will compare results between the two groups to see whether the stretching device improves recovery after knee replacement.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Age 40 years or older

• Undergoing primary total knee replacement surgery

• Knee flexion less than 105 degrees at approximately 4 weeks after surgery

• Considered a candidate for motion-restoring surgery, with any surgery delayed until after 2 months of nonoperative treatment

Locations
United States
Texas
INOV8 Orthopedics
RECRUITING
Houston
Time Frame
Start Date: 2025-12-09
Estimated Completion Date: 2029-12
Participants
Target number of participants: 150
Treatments
Active_comparator: Physical Therapy Only
Participants will receive standard postoperative physical therapy following primary total knee arthroplasty according to the treating clinician's usual rehabilitation protocol.
Experimental: Hydraulic high-Intensity Stretch Device Plus Standard Physical Therapy
Participants will receive standard postoperative physical therapy and will use a hydraulic high-intensity stretch device (Ermi Knee Flexionater) at home in accordance with the study protocol.
Related Therapeutic Areas
Sponsors
Leads: Ermi LLC

This content was sourced from clinicaltrials.gov